SANDIMMUN NEORAL SANDIMMUN NEORAL SANDIMMUM NEORAL D SANDIMMUN CYLOR C-SPOR SCOTS CYCLOSPORIN SCOTS CYCLOSPORIN SCOTS CYCLOSPORIN SCOTS CYCLOSPORIN CONSUPREN CONSUPREN CONSUPREN CONSUPREN BIORAL BIORAL BIORAL NEOCYSPIN NEOCYSPIN NEOCYSPIN NEOCYSPIN DIABETONE CIPOL CIPOL-N CIPOL-N CIPOL-N CIPOL-N CIPOL-N C-ZINE GRAMUNE

Dose: 150 to 500 mg
Single Dose: 320 (325)
Frequency: 24 hourly
Route: PO
Instructions: Maintenance

Dose: 2.5 to 0 mg/kg
Single Dose: 1.2 (1.25)
Frequency: 12 hourly
Route: Oral
Instructions: Post operative for 1-2 Weeks

Cyclosporin A also known as Ciclosporin. . It is of Natural origin and belongs to Polypeptide. It belongs to Immune Modifiers pharmacological group on the basis of mechanism of action and also classified in Antidotes and Immunosuppressant Agent pharmacological group.The Molecular Weight of Cyclosporin A is 1202.00. Its pKa is unionized.

Cyclosporin A is contraindicated in conditions like Renal impairment,Uncontrolled infection,Uncontrolled hypertension,Malignancy.

The severe or irreversible adverse effects of Cyclosporin A, which give rise to further complications include Hypertension.Cyclosporin A produces potentially life-threatening effects which include Convulsions, Nephrotoxicity, Neoplasia. which are responsible for the discontinuation of Cyclosporin A therapy.The symptomatic adverse reactions produced by Cyclosporin A are more or less tolerable and if they become severe, they can be treated symptomatically, these include GI reactions, Tremor, Hepatotoxicity, Paresthesias, Hypertrichosis, Gingival hypertrophy, Hyperesthesia.

Cyclosporin A is primarily indicated in conditions like Allograft rejection prevention, Allograft rejection treatment, Atopic dermatitis, Bone marrow transplantation, Organ transplantation, Severe active rheumatoid arthritis, Severe psoriasis, and can also be given in adjunctive therapy as an alternative drug of choice in Asthma, Nephrotic syndrome, Primary biliary cirrhosis, Psoriasis, Sarcoidosis, Systemic lupus erythematosus, Ulcerative colitis, Uveitis.

Cyclosporin A is known to interact with other drugs, the details of drug interactions is as follows:DrugDetailsSeverityOnsetManagementAceclofenacThe risk of nephrotoxicity increases when aceclofenac is used with cyclosporin.Afatinibcyclosporin may increase the level of afatinibuse alternative or reduced doseAliskirenAllopurinolAllopurinol possibly increases plasma concentration of ciclosporin (risk of nephrotoxicity).Amiloride (HCl)Amiodarone (HCl)Amiodarone may decrease the metabolism of CycloSPORINE by inhibition of CYP450 3A4 result in increase blood concentration of cyclosporin enhances the risk of nephrotoxicity and neurotoxicity. ModerateMonitor increased serum concentrations and/or toxicity of cyclosporine if amiodarone is initiated/dose increased, or decreased serum concentrations if amiodarone is discontinued/dose decreased. A reduction in cyclosporine dosage will likely be needed.AmobarbitalAmlodipine accelerates the metabolism of cyclosporin (reduced effects).AtazanavirAtazanavir possibly increases plasma concentration of Cyclosporin.AtorvastatinCyclosporin may increase the serum concentration of Atorvastatin. MajorMonitor altered effects (eg, increased serum CPK, myopathy, rhabdomyolysis) of Atorvastatin if Cyclosporin is introduced or discontinued, or when its dosage is modified.AzapropazoneAzithromycinMacrolides (e.g Azithromycin) possibly inhibit metabolism of Ciclosporin (increased plasma concentration).Benazepril (HCl)BosentanPlasma concentration of Bosentan increased by Cyclosporin (also plasma concentration of cyclosporin reduced -avoid concomitant use).Bromocriptine (Mesylate)CaptoprilCaptopril may enhance the nephrotoxic effect of CycloSPORINE.MajorDelayedMonitor for increased signs and symptoms of nephrotoxicity during concomitant therapy with cyclosporine and Captopril. Maintenance of adequate hydration (caution with diuretic use) may reduce of risk of ill effects.CarbamazepineCarbamazepine accelerates metabolism of Cyclosporin (reduced plasma concentration)due to hepatic metabolism induction.MajorBetter to avoid this combination or monitor serum concentration of cyclosporine.CelecoxibCerivastatin SodiumChloroquineCimetidine (HCl)Cimetidine competitively inhibits creatinine clearance for renal tubular secretion,increases serum creatinine and may antagonize cyclosporine-induced inhibition of interleukin-2 production in patients treated with cyclosporine.MinorRanitidine may be preferable to cimetidine in patients using cyclosporine.CinoxacinCiprofloxacinCiprofloxacin increases the serum concentration of cyclosporin. The risk of cyclosporine induced neurotoxicity and nephrotoxicity may also be increased.ModerateCyclosporine levels and renal function must be closely monitored.CisaprideCyclosporin increases the plasma concentration of cisapride by inhibiting its metabolic clearence.Increased level of cisapide results in prolongation of QT interval on ECG, ventricular arrythmia, cardiac arrest and sudden death.MajorCoadministration should be avoided.ClarithromycinCyclosporin enhances the blood concentration of clarithromycin by inhibiting hepatic and intestinal metabolism result in increased risk of nephrotoxicity and neurotoxicity.ModerateCoadministration of these agents should be avoided. Blood level of cyclosporin and renal function should be checked frequently. Adjust the dose accordingly.Patient should notify their physician if experience nausea, vomiting, diarrhea, abdominal pain, dizziness, fatigue, or headache.ColchicineCo-TrimoxazoleDanazolDanazol can increase plasma concentration of cyclosporinDexibuprofenDiclofenac (K)Diclofenac (Na)nephrotoxity may occurDigoxinCycloSPORINE may decrease the metabolism of Digoxin.ModerateRapidMonitor for toxic effects of Digoxin if cyclosporine is initiated/dose increased, or decreased effects if cyclosporine is discontinued/dose decreased. Diltiazem (HCl)DocetaxelEnalapril (Maleate)ErythromycinErythromycin by interfering in hepatic and intestinal metabolism increases blood concentration of cyclosporine through CYP450 3A4 inhibition and may result in nephrotoxicity and neurotoxicity.ModerateGenerally avoid.Adjust dose and check cyclosporine blood levels and renal function.Estradiol (Valerate)EthylestrenolEthynodiol (Diacetate)EtodolacFenbufenFenoprofenFloctafenineFluconazoleHigh doses(more than 200 mg per day) of fluconazole can increase serum concentration and toxicity of cyclosporine through CYP450 3A4 hepatic and or gut wall metabolism inhibition.Moderatedose adjustmnet and monitoring of renal function and serum cyclosporine levels are required.FlurbiprofenRisk of nephrotoxicity increases if given with cyclosporin.Fluticasone PropionateFoscarnet (Na)FosphenytoinGallopamilGentamicinIndomethacinIndomethacin exacerbate the nephrotoxic effect of cyclosporin.ModerateClosely monitor for renal functions.ItraconazoleItraconazoleKetoconazoleKetoconazoleKetoprofenLevofloxacinConcomitant use of levofloxacin and cyclosporin increases nephrotoxicity.LovastatinMeclofenamic AcidMeloxicamMelphalanMethylprednisoloneMethylprednisoloneConcomitant use can lead to convulsionsMethyltestosteroneCoadministration with androgens or anabolic steroids may increase the blood concentrations of cyclosporine. The exact mechanism of interaction is unknown but may involve competitive inhibition of the CYP450 3A4 metabolism of cyclosporine. There have been case reports of transplant patients who developed cyclosporine toxicity following the addition of methyltestosterone or danazol. In addition, a pharmacokinetic study in one patient found that cyclosporine systemic exposure (AUC) increased 65% during coadministration with danazol, despite a reduction in cyclosporine dose. The interaction has not been reported with other androgens or anabolic steroids but may theoretically occur due to the structural similarities of these agents. Pharmacodynamically, there is also a potential for additive hepatotoxicity during coadministration, as both cyclosporine and androgens can have adverse effects on the liver.ModerateCaution is advised if cyclosporine is prescribed with androgens or anabolic steroids. Cyclosporine blood levels, renal function, and liver function tests should be monitored frequently and the dosage adjusted accordingly, particularly following initiation, discontinuation or change of androgen dosage in patients who are stabilized on their cyclosporine regimen. Patients should be advised to notify their physician if they experience possible signs of cyclosporine toxicity such as nausea, vomiting, diarrhea, abdominal pain, dizziness, fatigue, headache, tremors, and convulsions.Metoclopramide (HCl)Metoclopramide increases the bioavailability of cyclosporinby increasing gastric emptying and may interfere with gastrointestinal degradation of cyclosporin, thus increases the risk of toxicity.ModerateCarefully monitor cyclosporin level, renal function and serum creatinine level of patient.MetolazoneMibefradil (Di HCl)Mitozantrone (HCl)MizolastineConcurrent use may increase the blood level of mizolastine and could increase the risk of side effects.ModafinilConcurrent use may decrease the effectiveness of modafinil.Mumps VaccineConcurrent use may weaken the immune system.Muromonab-cd3Likely interaction of MUROMONAB CD3 increasing the SERUM LEVEL of CYCLOSPORIN. NafcillinNafcillin sodium may decrease blood levels of cyclosporin.NicardipineNicardipineNorethisteroneNorfloxacinOctreotide (Acetate)OrlistatCyclosporine plasma levels were dcreased when Orlistat was coadministered with cyclosporineOxaliplatinYou should inform your doctor before using this combination.Do not start or stop any medicine without doctor or pharmacist approval.OxaprozinPerindoprilPhenobarbitonePhenytoin (Na)PitavastatinCyclosporine significantly increased pitavastatin exposureMajor Co-administration of cyclosporine with pitavastatin is contraindicated Potassium ChloridePrednisolone and Prednisonecylosporin decrease metabolism of prednisolone and prednisoneQuinaprilQuinapril may enhance the nephrotoxic effect of Cyclosporin A. MajorDelayedMonitor for increased signs and symptoms of nephrotoxicity during concomitant therapy with Cyclosporine and Quinapril. Maintenance of adequate hydration (caution with diuretic use) may reduce risk of ill effects. QuinupristinQuinupristin may increase cyclosporine concentrations.RifabutinRifampicinRifampicinRitonavirRosuvastatinCyclosporine significantly increased rosuvastatin exposure. Sevelamer HClReduced level of cyclosporin is observed when co-administered with sevelamer HClclose monitoring of blood concentrations should be considered during the use of combination and after its withdrawal.SirolimusSomatropinSomatropin administration may alter the clearance of Cyclosporin A.St.Johns Wort ExtractConcurrent use decrease the levels of Cyclosporin A.StreptomycinConcurrent use may cause toxicities to the kidneys.SulfisoxazoleSulindacSulphamethizoleConcurrent use with sulfonamides may increase the metabolism of cyclosporine, resulting in decreased plasma concentrations and potential transplant rejection, and additive nephrotoxicity.Plasma cyclosporine concentrations and renal function should be monitored.TeniposideCiclosporin decreases the clearance of teniposide, with increase terminal half-life, peak plasma concentration and toxicity.TenoxicamConcurrent use may increase the risk of nephrotoxicity.Testosterone (Esters)Tiaprofenic AcidTiaprofenic Acid may increase serum creatinine, potassium, blood pressure, and cyclosporine levels. Monitor cyclosporine levels and renal function carefully.TrandolaprilTrimethoprimTrimethoprim decreases the efficacy of cyclosporin.Combined use may increase the serum creatinine level.ModerateClosely monitor the renal function of patient and efficacy and safety of both drugs. An alternative antibiotic may be use.Vancomycin (HCl)VandetanibVandetanib is a moderate CYP3A4 inducer and can increase the metabolism of CYP3A4 substrates (e.g estroprogestatives, cyclosporin, tacrolimus, docetaxel, bortezomib)Caution should be taken to avoid this combination.Verapamil (HCl)Verapamil inhibit the CYP450 3A4 hepatic metabolism of cyclosporine and increased the risk of nephrotoxicity.ModerateCyclosporine level and renal function must be monitored.Warfarin (Na)Warfarin and cyclosporin both either enhance or reduce the effects of one another.ModerateClosely monitor the prothrombin time . INR and cyclosporin blood concentration. These interactions are sometimes beneficial and sometimes may pose threats to life. Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.

Drug should not be given to Pregnant Mothers, Cardiac / Hypertensive Patients, patients suffering from Kidney dysfunction, Geriatrics, and Neonates.If prescribing authority justifies the benefits of the drug against the possible damages he/she should reevaluate them and consult the reference material and previous studies.

Caps Store in a well closed container, Below 25°C. Soln Store in a well closed container, Below 25°C. Refrigeration and Freezing is not recommended.

'Cyclosporin A is not recommended for use during pregnancy or lactation. Immunosuppressant drug should not be given, where possible, to patients with acute infection, dosage reduction or withdrawal should be considered if infection develops, until the infection has been controlled. Blood counts and measurement of hemoglobin concentration should be carried out routinely; it helps to predict the onset of bone marrow depression. It must be handled with great care and avoid contact with skin and eyes and should not be inhaled. Cyclosporine can cause infection and possibly lymphoma, and is toxic to the kidneys. The use of this drug along with other drugs that are toxic to the kidneys must be closely monitored. It should be ingested and swallowed in its capsule without breaking the capsule. The liquid solution should only be mixed in a glass container. Pregnant or nursing women should not take this drug, and patients taking this drug will be more susceptible to infection. Therefore, crowds of people should be avoided, and no live vaccines should be adminstered to the patient without consulting the patient''s doctor. Patients should inform their doctor of any hypersensitivities or drug allergies they have before taking this drug. (Cyclosporine in both liquid and capsule form has some castor oil components in it, which could cause an allergic reaction for some.) Some allergic reactions to the I. V. solution may be severe. This drug has not been specifically studied for use with the elderly.'